Learn about short bowel syndrome (SBS), a rare malabsorption disorder, and why some patients may need a small bowel resection.

GATTEX® (teduglutide [rDNA origin]) for Injection is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or
fluids from intravenous (IV) feeding (parenteral support).

WHAT IS SHORT BOWEL SYNDROME (SBS)?

“I was eventually diagnosed with SBS after a series of surgeries to remove portions of my bowel.”

Brad, a patient living with SBS.

Short Bowel Syndrome is a serious and chronic disorder

SBS, sometimes called Short Gut Syndrome, is a serious, chronic and rare malabsorption disorder. People with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone. Malabsorption puts people at risk for diarrhea, dehydration, electrolyte disturbances and malnutrition.

Usually, people with SBS have undergone surgery to remove a large part of the intestine. After this surgery, called a bowel resection, the surface area of the intestine is decreased, which can limit the amount of nutrients and fluids the remaining intestines are able to absorb. When this happens, many patients have to receive nutrition and/or hydration through intravenous (IV) feeding, which is also called parenteral support (PS).

This occurs when the blood vessels can’t deliver enough blood, including oxygen and nutrients, to the intestines to allow it to function properly. In severe cases, this can lead to tissue death, which may make it necessary to remove a portion of the bowel.

A hernia occurs when the contents of a body cavity bulge out of the area where they are normally contained. In a strangulated hernia, the intestine that has bulged out is trapped and has its blood supply cut off. This damages the tissue, which may need to be removed via resection.

A fistula is an abnormal pathway leading from one part of the intestine to another part, to another organ in the body, or sometimes outside the body through the skin. If the fistula cannot be closed through conservative medical treatment, it may require a surgical bowel resection to prevent potential complications.

Peggy's Story

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Important Safety Information

What is the most important information I should know about GATTEX?

GATTEX may cause serious side effects, including:

Making abnormal cells grow faster

GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.

Polyps in the colon (large intestine)

Polyps are growths on the inside of the colon. Polyps were found in patients taking GATTEX in clinical studies. Your healthcare provider will have your colon checked for polyps within 6 months before starting GATTEX and have any polyps removed.

To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years and have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX.

Blockage of the bowel (intestines)

A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Bowel blockage was reported in patients taking GATTEX in clinical studies. Tell your healthcare provider if you have any of these symptoms of a bowel blockage:

Swelling (inflammation) or blockage of your gallbladder or pancreas

Swelling or blockage of the gallbladder or pancreas were reported in patients taking GATTEX in clinical studies. Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while you are using GATTEX. Tell your healthcare provider right away if you get stomach area (abdomen) pain and tenderness, chills, fever, change in your stools, nausea, vomiting, dark urine, or yellowing of your skin or the whites of eyes.

Fluid overload

Fluid overload and heart failure were reported in patients taking GATTEX in clinical studies. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Your healthcare provider will check you for too much fluid in your body. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.

The most common side effects of GATTEX include:

stomach area (abdomen) pain or swelling

skin reaction where the injection was given

nausea

headache

cold or flulike symptoms

vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I tell my healthcare provider before using GATTEX?

Tell your healthcare provider if you:

have cancer or a history of cancer

have or had polyps anywhere in your bowel (intestines) or rectum

have heart problems

have high blood pressure

have problems with your gallbladder, pancreas, kidneys

have any other medical condition

are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX.

are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You and your healthcare provider should decide if you will use GATTEX or breastfeed. You should not do both.

Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Your other healthcare providers may need to change the dose of any oral medicines you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Important Safety Information: GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.Click here for additional Important Safety Information.

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